Simplifying Global Compliance
Inspection Preparation Training for Drugmakers
Managing and leading people through an FDA inspection is a combination of art and science. And no one knows this better than Fred Branding. He has shepherded firms just like yours through hundreds of inspections.
Now he can lead you through the process of building your own inspection preparation plan so you’ll be ready the next time the FDA comes calling.
Spend 2 1/2 hours with Fred and you’ll learn:
- How FDA investigators prepare when they get the assignment to inspect your company
- What resources they review about your operations before they set foot on your property
- What training documents and regulations they must follow as part of the inspection
- How they craft 483 observations if they find problems
Take a look at Fred in action …
You’ll walk away knowing:
- How to develop inspection planning SOPs
- How to answer investigators’ questions fully — but not too fully
- What never to say to an FDA investigator
- How to discuss investigators’ observations — without arguing
- Making corrections during the inspection that satisfy the investigator
- And everything else you need to pass your next inspection
Inspection Preparation Training for Drugmakers also includes these valuable resources:
- Guide to preparing your subject matter experts for inspection
- FDAnews special report: How the FDA Trains and Prepares Investigators
- FDA Guidance, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection”
- Sample FDA Forms 482: Notice of Inspection; and 483: Inspectional Observations
- Printable presentation slides in note-taking format
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
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